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Neuroendocrine Changes in Cervical Spinal Manipulation and Mobilization Non-specific Mechanical Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cervical spinal manipulation
cervical spinal mobilization
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neck Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. . Subjects will be healthy male and females between 18 to 60 years of age.
  2. . Resting neck pain ≤ 30 days that is mechanical in nature without radiating pain below shoulder.
  3. . Neck Disability Index ≥ 10/50.
  4. . Negative Upper Cervical instability tests such as Sharper-Purser test, Alar ligament test and Transverse ligament test.

Exclusion Criteria:

  1. . Cervical Arterial Dysfunctions.
  2. . Serious medical conditions (CA, spinal cord injury).
  3. . History of instability disorders (History of neck injury, surgery, fractures, osteoporosis, arthritis, ankylosing spondylitis).
  4. . Neurological conditions (Nerve root compression, central nervous system involvement, myelopathy, fibromyalgia.
  5. . Endocrine dysfunctions (Autoimmune-related diseases, adrenal gland pathology, systematic metabolic disorders).
  6. . Pregnancy/Lactating/Postpartum.
  7. . Pending legal action regarding their neck pain.

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

cervical manipulation

cervical mobilization

postural correction education

Arm Description

The cervical spinal manipulation will consist of one session of a standard technique that will be performed by an experienced (>10 years) doctor of physical therapy practitioner. The technique is described by Gibbons and Tehan as a high-velocity, mid-range, low amplitude force at the segment of pain and/or segmental restrcition. The participant will lay comfortably in a supine position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual thrust at those levels. A maximum of 2 attempts for each side of the cervical spine will be allowed regardless of the having achieved joint cavitation. This type of cervical manipulation procedure is described by Gibbons and Tehan as "Minimal Leverage Thrust" and it results in optimal patient comfort while receiving the treatment thus reducing post-treatment soreness/pain.

The cervical spinal mobilization treatment will also consist of one session of a standard technique that will be performed by an experienced (>10 years) doctor of physical therapy practitioner. For this procedure, the participant will lay comfortably in a prone position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual forces at those segments. The magnitude of a mobilization-or how hard the therapist pushes on the spine-is usually reported as the magnitude of force. For an oscillatory posterior-anterior (PA) mobilization technique, the maximum magnitude of applied force is usually reported as the mean of the force peaks that occur during a specified period.34 The cervical mobilization will consist of oscillations of 1Hz and magnitude forces of 30 Newtons (N) for 30 seconds, 90N for 120 seconds and 30N for 30 seconds at the localized segment.

Participants will be presented with a standardized educational short video regarding the importance of postural correction movements.

Outcomes

Primary Outcome Measures

Neck Disability Index
Survey used to assess self-rated disability in patients with neck pain.

Secondary Outcome Measures

Numeric Pain Rating Scale
The questionnaire is used to capture the patient's level of pain by using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).
Global Ratio of Change
This is a 15-point scale to rate the patient's own perception of improved or deteriorated function.
Salivary Biomarkers
Salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected for each participant.

Full Information

First Posted
May 28, 2021
Last Updated
January 19, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT04911608
Brief Title
Neuroendocrine Changes in Cervical Spinal Manipulation and Mobilization Non-specific Mechanical Neck Pain
Official Title
Neuroendocrine Changes After Cervical Spinal Manipulation and Mobilization in Subjects With Non-specific Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim for this graduate student research project is to determine if cervical spinal mobilization releases similar neuropeptides and endogenous hormones as compared to cervical spinal manipulation and a control group. We hypothesized that application of cervical manipulations would result in a neuroendocrine response (SNS- HPA axis). By measuring salivary cortisol, oxytocin and DHEA, it may be possible to provide important information regarding the mechanisms and associations of pain modulation, anti-inflammatory and tissue healing after a biomechanical event.
Detailed Description
Participants will be completing three standardized questionnaires: The Neck Disability Index (NDI), Numeric Pain Rate Scale (NPRS), and the Global Ration of Change (GROC). These self-rated questionnaires will be used to capture the patient's level of pain, assess disability, and to quantify patient's improvement or deterioration over time, usually to either determine the effect of an intervention or to chart the clinical course of a condition. Participants will be providing four saliva samples: Collecting biomarkers in saliva requires reliable, accurate methods for proper storage and handling techniques with high-quality assays and validated testing protocols. For this study, salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected in the morning (between 8 am and 11 am) for each participant at preintervention (baseline), and 15, 30 and 60 minutes after intervention by using self-collection kits in accordance with the manufacturer's instructions for each biomarker (Salimetrics Inc). Participants will be receiving skilled interventions: Participants will be randomly assigned by using a computer-generated randomized table of numbers created prior to the start of data collection to one of the following three groups: cervical manipulation group, cervical mobilization group, no-touch group which will be receiving postural education. Cervical Spinal Manipulation (CSM) and Cervical Spinal Mobilizations (CSMob) are common techniques utilized by healthcare professionals to treat neck pain, low back pain and its effectiveness to treat musculoskeletal pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical manipulation
Arm Type
Experimental
Arm Description
The cervical spinal manipulation will consist of one session of a standard technique that will be performed by an experienced (>10 years) doctor of physical therapy practitioner. The technique is described by Gibbons and Tehan as a high-velocity, mid-range, low amplitude force at the segment of pain and/or segmental restrcition. The participant will lay comfortably in a supine position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual thrust at those levels. A maximum of 2 attempts for each side of the cervical spine will be allowed regardless of the having achieved joint cavitation. This type of cervical manipulation procedure is described by Gibbons and Tehan as "Minimal Leverage Thrust" and it results in optimal patient comfort while receiving the treatment thus reducing post-treatment soreness/pain.
Arm Title
cervical mobilization
Arm Type
Experimental
Arm Description
The cervical spinal mobilization treatment will also consist of one session of a standard technique that will be performed by an experienced (>10 years) doctor of physical therapy practitioner. For this procedure, the participant will lay comfortably in a prone position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual forces at those segments. The magnitude of a mobilization-or how hard the therapist pushes on the spine-is usually reported as the magnitude of force. For an oscillatory posterior-anterior (PA) mobilization technique, the maximum magnitude of applied force is usually reported as the mean of the force peaks that occur during a specified period.34 The cervical mobilization will consist of oscillations of 1Hz and magnitude forces of 30 Newtons (N) for 30 seconds, 90N for 120 seconds and 30N for 30 seconds at the localized segment.
Arm Title
postural correction education
Arm Type
No Intervention
Arm Description
Participants will be presented with a standardized educational short video regarding the importance of postural correction movements.
Intervention Type
Other
Intervention Name(s)
cervical spinal manipulation
Intervention Description
High-velocity, mid-range, low amplitude force at the segment of pain and/or segmental restriction. The participant will lay comfortably in a supine position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual thrust at those levels. A maximum of 2 attempts for each side of the cervical spine will be allowed regardless of the having achieved joint cavitation.
Intervention Type
Other
Intervention Name(s)
cervical spinal mobilization
Intervention Description
Participant will lay comfortably in a prone position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual forces at those segments.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
Survey used to assess self-rated disability in patients with neck pain.
Time Frame
change between baseline and 2 days
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
The questionnaire is used to capture the patient's level of pain by using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
change between baseline and 2 days
Title
Global Ratio of Change
Description
This is a 15-point scale to rate the patient's own perception of improved or deteriorated function.
Time Frame
change between baseline and 2 days
Title
Salivary Biomarkers
Description
Salivary oxytocin, cortisol and dehydroepiandrosterone (DHEA) will be collected for each participant.
Time Frame
change between baseline and 15, 30 and 60 minutes after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: . Subjects will be healthy male and females between 18 to 60 years of age. . Resting neck pain ≤ 30 days that is mechanical in nature without radiating pain below shoulder. . Neck Disability Index ≥ 10/50. . Negative Upper Cervical instability tests such as Sharper-Purser test, Alar ligament test and Transverse ligament test. Exclusion Criteria: . Cervical Arterial Dysfunctions. . Serious medical conditions (CA, spinal cord injury). . History of instability disorders (History of neck injury, surgery, fractures, osteoporosis, arthritis, ankylosing spondylitis). . Neurological conditions (Nerve root compression, central nervous system involvement, myelopathy, fibromyalgia. . Endocrine dysfunctions (Autoimmune-related diseases, adrenal gland pathology, systematic metabolic disorders). . Pregnancy/Lactating/Postpartum. . Pending legal action regarding their neck pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Everett Lohman, Dsc
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

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Neuroendocrine Changes in Cervical Spinal Manipulation and Mobilization Non-specific Mechanical Neck Pain

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